1. CONVATEC
1.1. Beta Bionics and ConvaTec announce partnership to bring Unomedical infusion set portfolio to the iLet Bionic Pancreas System
ConvaTec is a leading global manufacturer of widely popular infusion sets offering a variety of patient choice
Beta Bionics is developer of the iLet Bionic Pancreas System and is committed to device interoperability and patient choice
ConvaTec will manufacture infusion sets for delivery of both insulin and glucagon via the iLet Bionic Pancreas System
Beta Bionics, Inc., a medical technology company leveraging lifelong autonomous learning to develop and commercialise the world's first fully automated bionic pancreas, and ConvaTec Group, a leading global medical products and technologies company, announced on 17 July 2019 that ConvaTec's Unomedical subsidiary and Beta Bionics have entered into a collaboration and development agreement that will make portions of Unomedical's world‐class infusion sets available for use with the iLet Bionic Pancreas System.
The arrangement between Beta Bionics and ConvaTec creates a deep and meaningful partnership between the two companies for the benefit of the diabetes community. The arrangement is non‐exclusive and consistent with other Beta Bionics partnerships designed to protect patient choice. The Unomedical sets will be deployed in two pivotal trials testing the iLet in its insulin‐only and bihormonal (insulin and glucagon) configurations in 2020. ConvaTec's Unomedical subsidiary develops, produces, and supplies a range of disposable infusion sets used in insulin infusion therapy, including their highly popular flexible cannula sets currently used with insulin pumps today.
1.1.1. About the iLet Bionic Pancreas System
The iLet consists of a dual‐chamber, pocket‐sized, wearable medical device that autonomously controls blood sugar levels in people with diabetes. Embedded in the system are clinically tested mathematical dosing algorithms driven by lifelong autonomous learning to automatically calculate and dose insulin and/or glucagon as needed based on data from a continuous glucose monitor. To initialise the iLet, users enter only their body weight. Immediately thereafter, the iLet begins controlling blood sugar levels automatically, without requiring the user to count carbohydrates, set insulin delivery rates, or deliver bolus insulin for meals or corrections.
In previous home‐use studies in adults and children with T1D, these algorithms demonstrated dramatic improvements in glycaemic control relative to the standard of care. These improvements included significant reductions in blood glucose levels, in hypoglycaemia, and in intersubject and intrasubject glycaemic variability (New England Journal of Medicine, 2014, 371:313–25; Lancet Diabetes and Endocrinology, 2016, 4:233–43; Lancet, 2016, 389:369–80).
The iLet is effectively three medical devices in one. It can be configured as an insulin‐only bionic pancreas, a glucagon‐only bionic pancreas, or a dual‐hormone bionic pancreas (insulin and glucagon). The glucagon‐only configuration may be helpful in rare, chronic, low blood sugar conditions, such as congenital hyperinsulinism and insulinoma syndrome. Beta Bionics is committed to obtaining regulatory approval and commercialising all three iLet configurations.
1.1.2. About Beta Bionics
Beta Bionics is a for‐profit Massachusetts public benefit corporation founded in 2015 to commercialise the iLet, a revolutionary bionic pancreas that is driven by mathematical dosing algorithms, which incorporate lifelong autonomous learning to automatically control glycaemia. These mathematical dosing algorithms were developed in the Damiano Lab at Boston University and refined based on results from home‐use clinical trials in adults and children with T1D. Beta Bionics is a Certified B Corporation whose founders—in addition to Ed Damiano—include other parents of children with type 1 diabetes and people with type 1 diabetes. Beta Bionics is committed to acting in the best interests of the diabetes community and to profoundly disrupt the diabetes medical device industry by bringing the iLet to market as expeditiously and responsibly as possible. Beta Bionics is pursuing regulatory approval of its insulin‐only bionic pancreas, followed by its dual‐hormone system, which will also administer a glucagon analogue in order to raise blood sugar levels without the need to consume carbohydrates.
Beta Bionics operates in Massachusetts and California. For further information, please visit www.betabionics.com or follow Beta Bionics Facebook, YouTube, Instagram, LinkedIn, and Twitter @BetaBionics.
1.1.3. About ConvaTec
ConvaTec is a global medical products and technologies company focused on therapies for the management of chronic conditions. The Company is listed on the London Stock Exchange (stock symbol: CTEC) and has leading market positions in advanced wound care, ostomy care, continence and critical care, and infusion devices. ConvaTec's products provide a range of clinical and economic benefits, including infection prevention, protection of at‐risk skin, improved patient outcomes, and reduced total cost of care (www.convatecgroup.com).
2. MÖLNLYCKE HEALTH CARE
2.1. Mölnlycke acquires patent for smart solutions to detect infection in wounds
The Swedish medical solutions company, Mölnlycke, is acquiring a patent application from Innovation Skåne, which will help detect infections in wounds. Once developed, the patent is intended to play a major role in reducing the unnecessary use of antibiotics in wound care.
The incidence of infection in hard‐to‐heal chronic wounds, such as diabetic foot ulcers and venous leg ulcers, is high—and one in 20 patients undergoing surgery will develop a surgical site infection. However, infected wounds are costly, difficult to manage, and hard to detect. In many cases, expensive antimicrobials are used prophylactically to prevent infections or to treat them once they have been established.
Mölnlycke has entered into an agreement with the Swedish regional innovation company, Innovation Skåne, and acquired the ownership of the patent application. The purpose of the technology in the invention is to detect infections and alert caregivers that the wound needs attention. It will help to minimise the prophylactic use of antibiotics and reduce the risk of complications related to infections.
Barry McBride, Executive Vice President R&D said: “Antimicrobial resistance is an increasingly significant threat to public health worldwide. This exciting new technology will help reduce the incidence of serious infection and minimise the unnecessary use of antibiotics.”
Joakim Nelson, CEO of Innovation Skåne, said: “This is an example of innovations originating from employees in Region Skåne and demands in their daily work. We share Mölnlycke's goal of driving innovative improvements in healthcare and we are delighted Mölnlycke will be able to use this patent to help tackle a serious public healthcare issue.”
2.1.1. About Mölnlycke
Mölnlycke is a world‐leading medical solutions company. They develop and bring to market innovative wound care and surgical solutions along the entire continuum of care—from prevention to post‐acute settings. Their solutions provide value for money, supported by clinical and health economic evidence. The company was founded in 1849. Nowadays, their solutions are available in around 100 countries; they are the number 1 global provider of advanced wound care and single‐use surgical products; and are Europe's largest provider of customised trays. Their headquarters are in Gothenburg, Sweden, and have about 8000 employees around the world. Learn more at molnlycke.com.
2.1.2. About Innovation Skåne
Innovation Skåne is the regional innovation company. The company contributes to future public services and regional growth through innovation, by providing innovation management and support for Region Skåne's operations and the development of new industries and fast‐growing companies, which contribute to growth in Skåne. Innovation Skåne is fully owned by Region Skåne, Sweden's southernmost county council.
3. SMITH & NEPHEW
3.1. Smith & Nephew meniscal knee repair technology delivers 0% re‐operation rate and 100% meniscal healing at 6 months shows first ever study of horizontal cleavage tears
Smith & Nephew announced in July 2019 the results of the first ever prospective clinical trial to evaluate the effectiveness of repairing Horizontal Cleavage Tears (HCTs), one of the most common meniscal tears affecting approximately one‐third of patients with this injury. The STITCH Study is examining the effectiveness of repair using Smith & Nephew's NOVOSTITCH Meniscal Repair System, available only in the United States, which addresses complex meniscal tear patterns not adequately served by other repair systems, including HCTs.
STITCH enrolled 30 patients with meniscal tears at eight sites across the United States. Three endpoints were examined:
Meniscal healing upon second look needle arthroscopy,
Freedom from re‐operation, and
Improvements in knee pain and function as measured by Patient‐Reported Outcomes (PROs) including KOOS, IKDC, Lysholm, and Tenger scores.
Six‐month results across all three endpoints reported significant improvement in all PROs, including a 0% re‐operation rate at 6 months, and 100% meniscal healing upon second look arthroscopy as measured by no visible defect during in‐office, needle endoscopy.
“These initial STITCH results demonstrating successful HCT repair are very promising. This is exciting to see, as many patients are affected by these types of meniscal tears, which have previously been considered irreparable” said Dr. David Flanigan, director of the cartilage restoration programme at The Ohio State University Wexner Medical Centre and coauthor of STITCH.
Historically, HCTs were treated conservatively or by partial resection, commonly referred to as a meniscectomy, which may put the patient at risk for adverse changes to the knee joint, leaving them open to osteoarthritis or total knee replacement later in life. NOVOSTITCH is highly complementary to Smith & Nephew's leading FAST‐FIX◊ 360 Meniscal Repair System, which addresses vertical tears, the most commonly repaired meniscal injury today.
“There are currently more than 1.2 million meniscal tears treated surgically in the US each year with only 15‐20% of the cases receiving a meniscal repair, rather than removal,” stated Brad Cannon, President of Global Sports Medicine and ENT at Smith & Nephew. “With products like NOVOSTITCH PRO and FAST‐FIX 360, we see the opportunity to double this proportion in the medium term.”
The NOVOSTITCH device is designed for access and safety in tight knee joints and offers surgeons the potential to place circumferential compression stitches in locations previously not possible, thereby potentially expanding the meniscal repair option for many patients.
Study Principal Investigator and internationally recognised orthopaedic surgeon, Dr. Peter Kurzweil, Memorial Orthopaedic Surgical Group commented, “The STITCH Study is a ground‐breaking endeavor. To date, many orthopaedic surgeons still hold questions regarding the effectiveness of meniscal repair, and this initial data from our study endpoints are vastly encouraging. I'm looking forward to our future results.” The STITCH study will continue to follow patients for 2‐year post‐operation.
The 6‐month STITCH results were recently presented at the International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine (ISAKOS), Cancun, MX, in May 2019. To learn more about the NOVOSTITCH PRO, please visit: www.AllTearsAllRepairs.com.
4. COLOPLAST
Our bodies are different, and it is a challenge to create products to fit individual bodies. This is also the case when it comes to premature babies and kids. Coloplast was proud to present two additional and customised SenSura Mio ostomy care products, SenSura Mio Baby and SenSura Mio Kids. Coloplast now offers a full range of ostomy care products to fit everyone and everybody profile.
Although SenSura Mio, SenSura Mio Convex, and SenSura Mio Concave are designed to fit the individual shapes of adults with regular, inward, and outward body profiles, SenSura Mio Baby and SenSura Mio Kids are designed and developed especially for babies and kids.
“While it is uncommon for babies and kids to undergo stoma surgery, we want to make sure those who do, have the best possible products. Despite it being difficult to create a great fit for the littlest of users, our latest products do just that,” says CEO Kristian Villumsen, Coloplast.
“As a market leader, we are proud to offer innovative products like SenSura Mio Baby and SenSura Mio Kids, which helps these little ostomates live healthy lives and not be limited by their conditions,” says Mr. Villumsen.
4.1. New best practice guidelines by stoma care professionals
The SenSura Mio Baby products aim to provide longer wear time, as especially premature babies have sensitive skin, which needs as much peace and quiet as possible.
The new products include the best practice guidelines developed by paediatric stoma care nurses with solid experience with babies and kids living with a stoma.
4.1.1. Red Dot award winner
Both SenSura Mio Baby and SenSura Mio Kids have won the Red Dot Award: Product Design 2019. The “Red Dot” is the award for high‐quality design, and the international jury grants this seal of quality to products that feature an innovative and outstanding design.
“With the star‐shaped baseplate, SenSura Mio Kids is designed specifically for children's round bellies. It is exciting to see the innovative SenSura Mio Baby and SenSura Mio Kids products being recognised for its design. I believe that these products successfully combine functionality and design—this is design with a purpose,” says SVP of Global Marketing Rasmus Hannemann, Coloplast.
Int Wound J. 2019;16:1243–1245. 10.1111/iwj.13227